PHILADELPHIA, July 12 /PRNewswire-FirstCall/ -- Mutual Pharmaceutical Company/AR Scientific today announced the commercial introduction of QUALAQUIN(TM) (quinine sulfate capsules USP, 324 mg) for the treatment of uncomplicated Plasmodium falciparum malaria. QUALAQUIN is the first and only formulation of quinine sulfate to be evaluated and approved by the U.S. Food and Drug Administration (FDA). QUALAQUIN has been designated an orphan drug by the FDA.
Each bottle of QUALAQUIN capsules will be distributed with a comprehensive package insert outlining its safe and efficacious use. Wholesalers are expected to begin receiving supplies by the end of the week.
The most common adverse events associated with QUALAQUIN use are a cluster of symptoms called “cinchonism”, which occurs to some degree in almost all patients taking QUALAQUIN. Symptoms of mild cinchonism include headache, sweating, ringing in your ears, dizziness, change in color vision, nausea, flushing, mild hearing loss, blurred vision and changes in color perception. QUALAQUIN is not approved for patients with severe or complicated P. falciparum malaria or for the prevention of malaria. QUALAQUIN is not approved for the treatment or prevention of nocturnal leg cramps. QUALAQUIN is contraindicated in patients with a prolonged QT interval, G6-PD deficiency, myasthenia gravis, optic neuritis, or a known hypersensitivity to quinine. For full prescribing information, please call medication information at 888-351-3786.
About AR Scientific, United Research Laboratories & Mutual Pharmaceutical Company
AR Scientific is the branded unit of United Research Laboratories/Mutual Pharmaceutical Company, a privately-held company headquartered in Philadelphia and engaged in the research, development, manufacturing and commercialization of generic and branded pharmaceutical products, as well as the application of innovative intellectual property strategies to existing and future branded products. URL/Mutual currently has 250 ANDA approvals, 4 NDA approvals, a rapidly growing pipeline of generic and branded products, and currently manufactures 2.3 billion units annually.
Mutual Pharmaceutical Company/AR Scientific
CONTACT: Richard P. Foster, Vice President, Marketing and StrategicAnalysis, +1-215-697-1900
Web site: http://www.urlmutual.com/
